Following the shocking death of 47-year-old Saira Shaikh hours after suffering from adverse drug reaction (ADR) in a civic hospital, BMC has swung into action. It has instituted two parallel committees to investigate why the 28 women, who had been administered antibiotic injections Ceftriaxone and Cefotaxime, had taken ill and had to be admitted in Kurla Bhabha Hospital on Monday night.
"A three-member expert committee consisting of Dr Preeti Mehta, microbiologist, Dr Nithya Gogate, clinical pharmacologist and Dr Milind Nadkar, physician has been constituted to investigate the cause of ADR," said Dr SJ Nagda, director, major hospitals, BMC.
"The other inquiry committee under Dr Vidya Thakur, who is in-charge of BMC peripheral hospitals in eastern suburbs, will check whether drugs were administered correctly," said Sanjay Deshmukh, additional municipal commissioner (health), BMC.
Food and Drug Administration (FDA) officials seized treatment records of the deceased, Saira, from KEM Hospital on Thursday. She breathed her last on Tuesday night within 24 hours of having taken the antibiotic jab.
FDA officials have instructed stockists and hospitals to stop sale and use of 50,400 vials of Cefotaxime injection (batch number CT-SM10403) manufactured under the brand name, Sanocef, by Sanjivini Parenteral Drugs, Navi Mumbai, as also over thousand vials of Ceftriaxone injection (batch number 314-331) manufactured under the brand name, Sefxim, by Zee Labs, Himachal Pradesh, and sterile water for injection (batch number 3WT-259) manufactured by Parenteral Drugs Limited, Baddi, Himachal Pradesh, until the investigation is completed.
"We have inspected the manufacturing units of drug companies in Navi Mumbai and informed drug controller in Himachal Pradesh to investigate the case from their end," said Pramod Yasatwar, drug inspector, Zone 3, FDA.
A range of tests will be conducted on the drug samples to ascertain their level of sterility. "These sterile products should be contamination free. They will be tested for close to 14 days to observe if there is any growth of pyrogens or if there is undue toxicity. The results of the investigations will be available within 20-25 days," Yasatwar added.
Meanwhile, in an official statement, Sanjivini Parenteral Limited, said: "We have not received any complaint about Sanocef 1gm (Cefotaxime for injection) so far. We here by assured you that the products manufactured are of standard quality. However, the sale and use of the batch (of medicines) will be stopped as a precautionary measure until the investigation is complete."
More than 50% of patients are still reeling under the after effects of the ADR. They had been shifted to KEM and Sion hospitals late on Monday after bouts of breathlessness, convulsions, vomiting, headache and chest pain.
Eleven of the patients—two from Sion and nine from KEM—were discharged; 16 still have stomach ache and fever. "We will discharge patients only after making sure they are well. Some of them are still ill," said Dr Nivedita Moulick, head, department of medicine in Sion Hospital.
Investigations will on following:
1. Whether drugs were stored improperly or in unsuitable storage condition.
2. Whether syringes used were contaminated.
3. Quality of drugs and injection water.
4. Method of administration of reconstituted injection (it's in powder form and is mixed with sterile water).
5. Whether reconstituted solution was administered within three minutes.
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